EANM guideline on the validation of analytical methods for radiopharmaceuticals

• Main Authors: Nic Gillings (Author), Sergio Todde (Author), Martin Behe (Author), Clemens Decristoforo (Author), Philip Elsinga (Author), Valentina Ferrari (Author), Olaug Hjelstuen (Author), Petra Kolenc Peitl (Author), Jacek Koziorowski (Author), Peter Laverman (Author), Thomas L. Mindt (Author), Meltem Ocak (Author), Marianne Patt (Author)
• Format: Book
• Published: SpringerOpen, 2020-02-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Abstract Background To fulfil good manufacturing requirements, analytical methods for the analysis of pharmaceuticals for human and vetinary use must be validated. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has publ...